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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; EXTERNAL COMPONENT
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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; EXTERNAL COMPONENT Back to Search Results
Model Number SAMBA 2 MAGNET SYSTEM [AP407 MAGNET SYSTEM]
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pressure Sores (2326)
Event Date 07/13/2022
Event Type  Injury  
Event Description
The device was activated in (b)(6) 2022 with a strength #3 magnet and the user started to experience burning sensation after 8 days.Another 5 days later on (b)(6) 2022 there was necrosis of the skin and the ap was not used until this healed.Afterwards the magnet was switched to a strength #1 but it was too weak so a strength #2 was used.This report refers to 9710014-2023-001047.For further information please refer to this report.
 
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Brand Name
BONEBRIDGE
Type of Device
EXTERNAL COMPONENT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU 
MDR Report Key18197994
MDR Text Key328894143
Report Number1066702-2023-00015
Device Sequence Number1
Product Code MPV
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/10/2023,11/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberSAMBA 2 MAGNET SYSTEM [AP407 MAGNET SYSTEM]
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/10/2023
Event Location Other
Date Report to Manufacturer11/10/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
Patient SexFemale
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